CardiAMP HF Trial National Co-Principal Investigator; Professor of Medicine, University of Wisconsin School of Medicine and Public Health
Appears in 1 story
Presented late-breaking trial results at THT 2026
In March 2026, the FDA accepted BioCardia's pre-submission package for the Helix Transendocardial Delivery Catheter, the first catheter that injects cell and gene therapies directly into heart muscle, and scheduled a formal meeting for Q2 2026. The device, backed by fifteen clinical trials, uses a small helical needle anchored within the beating heart to precisely deliver therapeutic agents to damaged tissue; CDRH leads the review in consultation with CBER.
Updated May 27
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